Manager Quality Assurance

POSITION PURPOSE

The position responsibility covers all associated Quality Assurance and Quality Control related activities within the Jonesboro, AR facility.

This incumbent serves as a key member of the site leadership team, and will interact routinely with Manufacturing Management, Operations, R&D, Sales and Marketing, as well as Corporate Quality and Regulatory Affairs.

The incumbent will provide leadership and direction, ensuring the manufacture and distribution of products are within Nice-Pak standards as well as State and Federal Regulations.

This position will also help implement Statistical process control throughout manufacturing and support the continuous development of cGMP and ISO quality system requirements.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

Staff Management :

• Provide leadership in Safety, Quality and Service through the use of continuous improvement. Ensure all personnel perform their jobs in a safe manner complying with company safety standards and rules.
• Manage the site Quality activities required to maintain the Nice-Pak Quality Management System, ISO requirements and Federal Regulations.
• Execute performance management process for all team members including : Manage team’s annual goals to ensure they meet the .

Specific, Measurable, Achievable, Relevant, and Time bound) criteria.Support development and accountability.

Ensure team’s compliance to company policies and SOP’s.

Performance Management :

• Ensure people are functioning in a high state of readiness and compliance, and all established criteria are met for testing and product release.
• Ensures that all documentation regarding Nice-Pak’s Quality Management System requirements are maintained, including updated as needed to effectively evolve the system to meet future requirements.
• Support all external and internal audits including, but not limited to, regulatory inspections, customer visits, third party assessments.

This includes not only facilitation, but also follow through on any and all corrective measures.

• Manage the disposition of all hold product efficiently, including communication of rework, Material Destruction Requests, and other necessary activities.
• Support the QMS as it relates to the effective management of Quality processes such as CAPA, Non-conformance, OOS, Management of Change, and Deviations.
• Define and implement necessary Quality related training for all areas of Quality compliance.
• Establish appropriate Quality metrics and support actions plans necessary to deliver expected results.
• Support all cross functional efforts to deliver on expected Safety, Operations, Service, and Quality metrics for the site.

Communication :

• Ensure appropriate training and understanding of processes are provided to the organization to optimize the functions responsibilities.
• Provide data and facilitate monthly Quality Review Committee and Quarterly Town Hall meetings.
• Responsible to attend, participate and share information in daily communication meetings.
• Foster an environment of open communication and servant leadership.
• Communicate with vendors and customers as necessary on quality related issues.

Training :

• Ensure that all team members are trained to perform the job function for which they are assigned.
• Ensure training is current and not past due.
• Assist the supervisors in developing, training and mentoring associates through regular feedback, participate in group decision-making and foster open communications.
• Assist in setting priorities.

QUALIFICATIONS

EDUCATION / CERTIFICATION :

University Degree in Biology or Chemistry, or equivalent experience.

REQUIRED KNOWLEDGE :

Experienced leader in Quality Assurance and / or Quality Control.

Proficiency in Microsoft platforms, including but not limited to Word, Excel, Visio, Excel and Adobe Acrobat.

Robust understanding of cGMP’s, ISO 22716, and ISO 9001.

CAPA and Root Cause Analysis.

Understanding of Quality Control requirements for analytical and microbial laboratories.

Understanding of FDA requirements for cosmetic and OTC manufacturing.

Understand EPA requirements for Disinfecting products.

EXPERIENCE REQUIRED :

4 years of leadership experience working in a regulated manufacturing environment (Food, Pharmaceutical, or Cosmetic Manufacturing preferred).

Experience in conducting facility and system audits and leading corrective action teams. Able to multi-task and coordinate project-based activities.

SKILLS / ABILITIES :

Lead a team by example. Strong communication and presentation skills. Strong Root Cause Analysis and Problem-Solving Skills.

Manage a team budget and drive cost out annually. Ability to lead a diverse team in a professional manner. Proficient computer skills to support enterprise resource planning (ERP) (such as Red Prairie, SAP, AS400, Dynamic 365, Oracle) and electronic Quality Management Systems (such as Intelex, MasterControl, Harford, LIMS, Labware, Specright).

WORKING CONDITIONS

NONE :

No hazardous or significantly unpleasant conditions.

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